Schizoaffective DisorderNCT00942981
Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography
An observational study of Schizoaffective Disorder and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- What is being tested?
- PET
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It will include 100 patients with schizophrenia, schizoaffective disorder or other psychotic disorders aged 18-60, and 230 healthy controls, aged 18-90.
Who may be able to join
- Subjects will be recruited among individuals volunteering for NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings (PI: Karen Berman, M.D.), NIH protocol 00-M-0085 Structural and Functional Imaging of Neuropsychiatric Patients and Normal Volunteers with 3.0 Tesla MRI and Magnetoencephalography. (P.I.: Karen Berman, MD) or NIH protocol 89-M-0160 "Inpatient Evaluation of Neuropsychiatric Patients" (PI: Daniel Eisenberg, M.D.). Most included patients, with schizophrenia, schizoaffective disorder or other non-excluded psychotic disorders, will be managed on the NIMH inpatient ward for the duration of their participation.
- Only adult subjects who are able to provide informed consent will be studied.
- Patients will be between 18 and 60 years of age. Healthy controls will be matched by age and sex to the patients. In addition, to study age effect on DA receptors, healthy controls will be included up to the age of 90 years.
- Control subjects must be healthy based on history, laboratory and physical exam obtained through the above mentioned protocols.
Who cannot join
- -Subjects will be excluded if they don t fit the study requirements regarding age, ability to provide informed consent, absence of significant general medical, neurological or psychiatric disorders (except the disorder object of study), or intake of substances that
- interfere with central dopaminergic signaling.
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
- Pregnant or breast feeding
- Current psychiatric illness except for patients with schizophrenia, schizoaffective disorder or other psychotic disorder
- Secondary causes of schizophrenia-like syndromes, e.g. amphetamine abuse, brain infarction, tumor, or trauma
Show all 16Show fewer
- Neurological disorders except those of exclusively peripheral location
- Current or prior use (within 4 weeks) of substances that interfere with central dopaminergic signaling (e.g. antipsychotics, dopamine receptor agonists, anticholinergics, MAO-B inhibitors)
- History of any (excepting nicotine- related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
- Cumulative lifetime history of any (excepting nicotine -related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
- Severe systemic disease, such as hypothyroidism not compensated by medication
- Laboratory tests with clinically significant abnormalities
- History of a significantly abnormal EEG, cranial CT or MRI
- Conditions that increase risk for MRI (pacemaker devices, ferromagnetic metal implants, etc.)
- Prior participation in other research protocols such that radiation exposure would exceed the annual NIH RSC limits
- Any medical condition that in the opinion of the investigators would interfere with the safe conduct of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions.
- The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia.
Read more
Objectives:
- To study the amount and distribution of two types of dopamine receptors.
Eligibility:
- Individuals between the ages of 18 and 60 who have schizophrenia.
- Healthy volunteers between the ages of 18 and 90.
Design:
- Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples.
- Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy.
- To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan.
- The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.
Read the detailed description
OBJECTIVES
Dopaminergic (DA) modulation of brain function is disturbed in several disabling psychiatric disorders and represents the target of key psychopharmacologic agents, such as neuroleptics. Schizophrenia has been considered a prototype of dysregulated DA signaling, with associated prefrontal cortex (PFC) dysfunction. Prevailing views attribute key symptoms of schizophrenia to deficient DA signaling within mesocortical DA tracts. Little is known, however, about the pre-, intra-, and post-synaptic processes that contribute to dopaminergic dysregulation. Regional cortical DA activity, critical to these processes, has been difficult to measure in patients with the available imaging techniques. The current clinical study aims to address this open issue by taking advantage of two recently developed positron emission tomography (PET) radioligands, [(11)C]NNC-112 and [(18)F]Fallypride, that bind differentially and with a higher binding potential (BP) than previous compounds to the D(1) (NNC-112) or D(2/3) (fallypride) receptors. By measuring the regional BP of these two compounds, cortical and subcortical DA receptor anomalies will be characterized in schizophrenia. Within the Clinical and Translational Neuroscience Branch (CTNB), this PET protocol is expected to add crucial information about DA receptor status to ongoing regional cerebral blood flow (rCBF), magnetic resonance imaging (MRI), magneto-encephalography (MEG) and genetic studies. It will lead to an improved understanding of the modulatory influence of DA on frontal lobe functioning and facilitate the study of how genetic polymorphisms interact with regional changes in D(1) and D(2/3) receptors to increase the risk for schizophrenia.
Some specific hypotheses to be tested are as follows:
D1 BP in frontal cortex will be affected by age, elevated in schizophrenia and inversely correlated with cognitive performance in patients and healthy controls.
Cortical D2/3 receptor BP will be affected by age and inversely correlated with performance on tests of frontal lobe function in patients and healthy controls.
Striatal D2/3 receptor BP will be altered in patients.
Polymorphisms in the catechol-O-methyl transferase (COMT), D1 and D2 genes as well as other schizophrenia risk genes will affect DA receptor BP in frontal cortex.
The ratio of cortical D1 and D2/3 receptor BPs will be affected by age and related to risk for schizophrenia, cognitive performance and polymorphisms in the COMT gene and other schizophrenia risk genes
STUDY POPULATION
It will include 100 patients with schizophrenia, schizoaffective disorder or other psychotic disorders aged 18-60, and 230 healthy controls, aged 18-90. Fifty of the controls will be matched to the patients by age and sex.
DESIGN
Dopamine D(1) and D(2/3) receptor regional binding potentials (BP) will be quantified by PET in medication-free patients and controls. High resolution T1-weighted magnetic resonance imaging (MRI) scans will be obtained for co-registration purposes. Additionally, through enrollment in other ongoing protocols (00-M-0085, 90-M-0014, 01-M-0232, 95-M-0150, 89-M-0160), rCBF, functional MRI, cognitive and genetic data will be obtained and compared with D(1) and D(2/3) receptor BP data obtained from this protocol.
OUTCOME MEASURES
Brain dopamine D(1) and D(2/3) receptor regional binding potentials measured by [[(11)C]NNC-112 and [(18)F]Fallypride PET.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Being tested
- PET
- Keywords
- PET Study, (18F) Fallypride, (11C)NNC-112, D-1 Receptors, Schizophrenia, Natural History, Schizoaffective Disorder, Healthy Volunteer, HV
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDrug
Brain dopamine D1 and D2/3 receptor regional binding potentials measured by [11C]NNC-112 and [18F]Fallypride PET.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | healthy volunteers Receives: Drug: PET | |
| patients | patients with schizophrenia, schizoaffective disorder or other psychotic disorders aged18-60 Receives: Drug: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain dopamine D1 and D2/3 receptor regional binding potentials
Brain dopamine D1 and D2/3 receptor regional binding potentials
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study start13 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karen F Berman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942981
- Sponsor's protocol ID
- 090176
- Other IDs
- 09-M-0176
- Status last verified
- 29 Sep 2026
- First submitted
- 18 Jul 2009
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eisenberg DP, Blackman RK, Tietcheu MG, Kohn PD, Bettina JS, Kolachana B, Gregory MD, Berman KF. Genetic risk for treatment resistant schizophrenia and corresponding variation in dopamine synthesis capacity and D2/3 receptor availability in healthy individuals. Mol Psychiatry. 2025 Jun;30(6):2645-2652. doi: 10.1038/s41380-024-02873-2. Epub 2024 Dec 27.
PubMed 39730881Ianni AM, Eisenberg DP, Boorman ED, Constantino SM, Hegarty CE, Gregory MD, Masdeu JC, Kohn PD, Behrens TE, Berman KF. PET-measured human dopamine synthesis capacity and receptor availability predict trading rewards and time-costs during foraging. Nat Commun. 2023 Sep 30;14(1):6122. doi: 10.1038/s41467-023-41897-0.
PubMed 37777515Hegarty CE, Ianni AM, Kohn PD, Kolachana B, Gregory M, Masdeu JC, Eisenberg DP, Berman KF. Polymorphism in the ZNF804A Gene and Variation in D1 and D2/D3 Dopamine Receptor Availability in the Healthy Human Brain: A Dual Positron Emission Tomography Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Jan;8(1):121-128. doi: 10.1016/j.bpsc.2020.12.006. Epub 2021 Mar 9.
PubMed 33712377
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT00942981
- Acronym / sponsor ID
- 090176
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- PET Study, (18F) Fallypride, (11C)NNC-112, D-1 Receptors, Schizophrenia, Natural History, Schizoaffective Disorder, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 13 Nov 2009 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions.
- The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia.
Objectives:
- To study the amount and distribution of two types of dopamine receptors.
Eligibility:
- Individuals between the ages of 18 and 60 who have schizophrenia.
- Healthy volunteers between the ages of 18 and 90.
Design:
- Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples.
- Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy.
- To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan.
- The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.
Detailed description
OBJECTIVES
Dopaminergic (DA) modulation of brain function is disturbed in several disabling psychiatric disorders and represents the target of key psychopharmacologic agents, such as neuroleptics. Schizophrenia has been considered a prototype of dysregulated DA signaling, with associated prefrontal cortex (PFC) dysfunction. Prevailing views attribute key symptoms of schizophrenia to deficient DA signaling within mesocortical DA tracts. Little is known, however, about the pre-, intra-, and post-synaptic processes that contribute to dopaminergic dysregulation. Regional cortical DA activity, critical to these processes, has been difficult to measure in patients with the available imaging techniques. The current clinical study aims to address this open issue by taking advantage of two recently developed positron emission tomography (PET) radioligands, [(11)C]NNC-112 and [(18)F]Fallypride, that bind differentially and with a higher binding potential (BP) than previous compounds to the D(1) (NNC-112) or D(2/3) (fallypride) receptors. By measuring the regional BP of these two compounds, cortical and subcortical DA receptor anomalies will be characterized in schizophrenia. Within the Clinical and Translational Neuroscience Branch (CTNB), this PET protocol is expected to add crucial information about DA receptor status to ongoing regional cerebral blood flow (rCBF), magnetic resonance imaging (MRI), magneto-encephalography (MEG) and genetic studies. It will lead to an improved understanding of the modulatory influence of DA on frontal lobe functioning and facilitate the study of how genetic polymorphisms interact with regional changes in D(1) and D(2/3) receptors to increase the risk for schizophrenia.
Some specific hypotheses to be tested are as follows:
D1 BP in frontal cortex will be affected by age, elevated in schizophrenia and inversely correlated with cognitive performance in patients and healthy controls.
Cortical D2/3 receptor BP will be affected by age and inversely correlated with performance on tests of frontal lobe function in patients and healthy controls.
Striatal D2/3 receptor BP will be altered in patients.
Polymorphisms in the catechol-O-methyl transferase (COMT), D1 and D2 genes as well as other schizophrenia risk genes will affect DA receptor BP in frontal cortex.
The ratio of cortical D1 and D2/3 receptor BPs will be affected by age and related to risk for schizophrenia, cognitive performance and polymorphisms in the COMT gene and other schizophrenia risk genes
STUDY POPULATION
It will include 100 patients with schizophrenia, schizoaffective disorder or other psychotic disorders aged 18-60, and 230 healthy controls, aged 18-90. Fifty of the controls will be matched to the patients by age and sex.
DESIGN
Dopamine D(1) and D(2/3) receptor regional binding potentials (BP) will be quantified by PET in medication-free patients and controls. High resolution T1-weighted magnetic resonance imaging (MRI) scans will be obtained for co-registration purposes. Additionally, through enrollment in other ongoing protocols (00-M-0085, 90-M-0014, 01-M-0232, 95-M-0150, 89-M-0160), rCBF, functional MRI, cognitive and genetic data will be obtained and compared with D(1) and D(2/3) receptor BP data obtained from this protocol.
OUTCOME MEASURES
Brain dopamine D(1) and D(2/3) receptor regional binding potentials measured by [[(11)C]NNC-112 and [(18)F]Fallypride PET.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Drug: PEThealthy volunteers |
| patients | – | Drug: PETpatients with schizophrenia, schizoaffective disorder or other psychotic disorders aged18-60 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It will include 100 patients with schizophrenia, schizoaffective disorder or other psychotic disorders aged 18-60, and 230 healthy controls, aged 18-90.
Key inclusion criteria (4 listed)
- Subjects will be recruited among individuals volunteering for NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings (PI: Karen Berman, M.D.), NIH protocol 00-M-0085 Structural and Functional Imaging of Neuropsychiatric Patients and Normal Volunteers with 3.0 Tesla MRI and Magnetoencephalography. (P.I.: Karen Berman, MD) or NIH protocol 89-M-0160 "Inpatient Evaluation of Neuropsychiatric Patients" (PI: Daniel Eisenberg, M.D.). Most included patients, with schizophrenia, schizoaffective disorder or other non-excluded psychotic disorders, will be managed on the NIMH inpatient ward for the duration of their participation.
- Only adult subjects who are able to provide informed consent will be studied.
- Patients will be between 18 and 60 years of age. Healthy controls will be matched by age and sex to the patients. In addition, to study age effect on DA receptors, healthy controls will be included up to the age of 90 years.
- Control subjects must be healthy based on history, laboratory and physical exam obtained through the above mentioned protocols.
Key exclusion criteria (16 listed)
- -Subjects will be excluded if they don t fit the study requirements regarding age, ability to provide informed consent, absence of significant general medical, neurological or psychiatric disorders (except the disorder object of study), or intake of substances that
- interfere with central dopaminergic signaling.
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
- Pregnant or breast feeding
- Current psychiatric illness except for patients with schizophrenia, schizoaffective disorder or other psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PETBrain dopamine D1 and D2/3 receptor regional binding potentials measured by [11C]NNC-112 and [18F]Fallypride PET. | Drug | healthy volunteers, patients |
Primary outcome
Brain dopamine D1 and D2/3 receptor regional binding potentials
Time frame: ongoing
Brain dopamine D1 and D2/3 receptor regional binding potentials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 39730881Eisenberg DP, Blackman RK, Tietcheu MG, Kohn PD, Bettina JS, Kolachana B, Gregory MD, Berman KF. Genetic risk for treatment resistant schizophrenia and corresponding variation in dopamine synthesis capacity and D2/3 receptor availability in healthy individuals. Mol Psychiatry. 2025 Jun;30(6):2645-2652. doi: 10.1038/s41380-024-02873-2. Epub 2024 Dec 27.
- Derived from this study: PubMed 37777515Ianni AM, Eisenberg DP, Boorman ED, Constantino SM, Hegarty CE, Gregory MD, Masdeu JC, Kohn PD, Behrens TE, Berman KF. PET-measured human dopamine synthesis capacity and receptor availability predict trading rewards and time-costs during foraging. Nat Commun. 2023 Sep 30;14(1):6122. doi: 10.1038/s41467-023-41897-0.
- Derived from this study: PubMed 33712377Hegarty CE, Ianni AM, Kohn PD, Kolachana B, Gregory M, Masdeu JC, Eisenberg DP, Berman KF. Polymorphism in the ZNF804A Gene and Variation in D1 and D2/D3 Dopamine Receptor Availability in the Healthy Human Brain: A Dual Positron Emission Tomography Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Jan;8(1):121-128. doi: 10.1016/j.bpsc.2020.12.006. Epub 2021 Mar 9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen F Berman, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizoaffective Disorder and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain dopamine D1 and D2/3 receptor regional binding potentials (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00942981, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.